UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020662 |
|---|---|
| Receipt number | R000023839 |
| Scientific Title | Effect on snoring and feasibility of Nasal Airway Stent |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2020/01/24 09:27:57 |
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Basic information
Public title
Effect on snoring and feasibility of Nasal Airway Stent
Acronym
Effect and feasibility of Nasal Airway Stent
Scientific Title
Effect on snoring and feasibility of Nasal Airway Stent
Scientific Title:Acronym
Effect and feasibility of Nasal Airway Stent
Region
| Japan |
Condition
Condition
Snoring
Classification by specialty
| Medicine in general | Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(1) Examine feasibility of using Nasal Airway Stent
(1) Examine the effect of using Nasal Airway Stent on snoring
(1) Examine the effect of using Nasal Airway Stent on apnea or hypopnea
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) feasibility of using Nasal Airway Stent
Before and After 4 days using Nasal Airway Stent, assessed for 3 days about
(2) snoring by digital voice recorder
(3) apnea and hypopnea (AHI) by Apnea hypopnea testing apparatus
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Nasal Airway Stent 7 days
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects who approve to take part in the study as examinees after informed consent
Key exclusion criteria
(1) Patient with sleep apnea syndrome undergoing medical treatment
(2) Patient with severe respiratory diseases
(3) Patient with severe liver, renal, heart, etc. diseases.
(4) Subject who cannot insert Nasal Airway Stent into the nasal cavity
(5) Subject who cannot perform examinations
(6) Subject judged as inadequate by researcher
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Sumi |
Organization
Tokyo Medical and Dental University
Division name
School of health sciences, Faculty of Medicine. Biofunctional Informatics, Biomedical Laboratory Science
Zip code
113-8519
Address
1-5-45 Yushima Bunkyo-ku Tokyo 113-8519 Japan
TEL
03-5803-5372
ysumi.pulm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Sumi |
Organization
Tokyo Medical and Dental University
Division name
School of health sciences, Faculty of Medicine. Biofunctional Informatics, Biomedical Laboratory Sci
Zip code
113-8519
Address
1-5-45 Yushima Bunkyo-ku Tokyo 113-8519 Japan
TEL
03-5803-5372
Homepage URL
ysumi.pulm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45 Yushima Bunkyo-ku Tokyo 113-8519 Japan
Tel
03-3813-6111
info.bec@tmd.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 20 | Day |
Last modified on
| 2020 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023839
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
